Home NDC 76125-918 BIVIGAM
Product NDC 76125-918
11-digit product format 761250918
Labeler code 76125
Product ID 76125-918_f2d0d740-6f43-454c-9898-627be94f18e8
Type PLASMA DERIVATIVE
Nonproprietary name HUMAN IMMUNOGLOBULIN G
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler KEDRION BIOPHARMA, INC.
Application BLA125389
Marketing category BLA
Marketing start 2013-02-04
Marketing end 0000-00-00
Substance HUMAN IMMUNOGLOBULIN G
Active strength 1 g/10mL
Pharmacologic classes Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BIVIGAM IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10% ADMA Biologics, Inc. a2244aa0-a6d0-11df-b385-0002a5d5c51b 2025-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125389
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76125-918-04 BIVIGAM 1 in 1 CARTON INJECTION, SOLUTION 1 2 76125-918-05 BIVIGAM 50 mL in 1 VIAL, GLASS INJECTION, SOLUTION 50 2 76125-918-09 BIVIGAM 1 in 1 CARTON INJECTION, SOLUTION 1 2 76125-918-10 BIVIGAM 100 mL in 1 VIAL, GLASS INJECTION, SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76125-918 BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [KEDRION BIOPHARMA, INC.] 2 Legacy NDC, 4 package rows 20170201_00dd9bbb-ee8b-f369-8cd1-6ce28925f118.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125389 Bivigam Immune Globulin Intravenous (Human) 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1809422 Bivigam 10 % in 100 ML Injection PSN 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809416 Bivigam 10 % in 50 ML Injection PSN 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809421 immunoglobulin G, human 10 % in 100 ML Injection PSN 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809414 immunoglobulin G, human 10 % in 50 ML Injection PSN 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809422 100 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] SBD 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809416 50 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] SBD 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809421 100 ML immunoglobulin G, human 100 MG/ML Injection SCD 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809414 50 ML immunoglobulin G, human 100 MG/ML Injection SCD 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809422 100 ML Bivigam 100 MG/ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809416 50 ML Bivigam 100 MG/ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809422 Bivigam 10 % per 100 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809416 Bivigam 10 % per 50 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809422 Bivigam 10 GM per 100 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809416 Bivigam 5 GM per 50 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809421 immunoglobulin G, human 10 % per 100 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809414 immunoglobulin G, human 10 % per 50 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809421 immunoglobulin G, human 10 GM per 100 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2 1809414 immunoglobulin G, human 5 GM per 50 ML Injection SY 00dd9bbb-ee8b-f369-8cd1-6ce28925f118 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 76125-918-04 76125091804 1 in 1 CARTON Historical 76125-918-05 76125091805 50 mL in 1 VIAL, GLASS 50 ml Historical 76125-918-09 76125091809 1 in 1 CARTON Historical 76125-918-10 76125091810 100 mL in 1 VIAL, GLASS 100 ml Historical